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G-CEM LinkForce™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
G-CEM LinkForce™ FDA UDI
Generic Name
Dental cement trial FDA UDI
Device Name
G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover FDA UDI
Model / Reference
012805 FDA UDI
Description
G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover FDA UDI

Identifiers

Catalog Number
012805 FDA UDI
Primary DI / UDI-DI
14548161292498 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental cement trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental cement trial

G-CEM LinkForce™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cement trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI 42b11fbd-9e8c-44ae-8433-d1b2d02f4eb3 36 fields · synced May 30, 2026